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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
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AIZU OLYMPUS CO., LTD. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE Back to Search Results
Model Number LTF-S190-5
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the deflectable videoscope had an image defect in which the subject was almost invisible and there was a strong vertical line noise.There were no reports of patient harm.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
Type of Device
FLEX DEFLECTABLE VIDEOSCOPE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
Manufacturer (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA   965-8520
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19027912
MDR Text Key339222043
Report Number9610595-2024-06895
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier04953170434648
UDI-Public04953170434648
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K201832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLTF-S190-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/02/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/25/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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